Guest user Created: Jul 23, 2018 Last commented: Jul 23, 2018

Cleaning of laboratory instruments

I am wondering how to registrate the cleaning of laboratory instruments. Currently we send out a reminder but we would like to have a form in which we can see at what date instrument is cleaned in stead of eg a two monthly reminder of all instruments in a certain part of the lab. So my question really is whether such a registration is necessary or what is really required by the ISO 13485?

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Strahinja Stojanovic Jul 23, 2018

Answer:

The standard has requirements for maintenance of the infrastructure (clause 6.3) and laboratory instruments can fit into this category as a process equipment (clause 6.3 b)). This clause requires organization to document requirements for maintenance activities (in your case cleaning) including the interval of performing these activities and records of the maintenance activities.

This means that you should have some record of the cleaning activities. This record can contain information on the date of the cleaning, person who performed the cleaning and optionally the type of the cleaning activities. Depending on the type of instruments you have and frequency of cleaning, you can have either separate record for each instrument or you can have one record for group of instruments.

Here you can download free preview of our Record of Infrastructure Maintenance https://advisera.com/13485academy/documentation/record-of-infrastructure-maintenance-iso-13485-2016/

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Jul 23, 2018

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